Clinical outcomes of a short-term family-focused intervention for patients with atrial fibrillation–A randomised clinical trial

Aims To evaluate a family-focused intervention for patients with atrial fibrillation (AF) in addition to conventional care and to establish its effect on health-related quality of life (HRQoL), anxiety, depression, AF symptoms, and family support. Background AF is a widespread heart disease affecting the well-being of patients and their family members physically and psychologically. Supporting patients and their family members could potentially facilitate regaining family strength and improve HRQoL. Methods Patients with newly diagnosed AF were randomised to standard care or additional family-focused intervention with change in global score of the Atrial Fibrillation Quality of Life Questionnaire (AFEQT) as primary outcome after six months’ follow-up. Secondary outcomes included the Hospital Anxiety and Depression Score, the European Heart Rhythm Association score, the Ice Expressive Family Functioning Questionnaire, and the Ice Family-Perceived Support Questionnaire (ICE-FPSQ). Results Sixty-eight patients received standard care (n = 35) or family focused intervention (n = 33). The median change at the six-month follow-up on the global AFEQT score was 4.17 (-1.46–9.17) in the control group and 5.83 (-2.5–30) in the intervention group, yielding a median difference of -1.67 (p = 0.500). Change in ICE-FPSQ showed significant positive scores in favour of intervention (p < 0.001); other secondary outcome changes were non-significant. Conclusion The family-focused intervention had a small positive but non-significant effect on HRQoL compared to standard care. To address the impact of AF on the patients and family members seems to improve anxiety and depression scores and perceived family support.


Background
Atrial fibrillation (AF) is the most common cardiac arrhythmia and is often described as the new epidemic among heart diseases (1). In 2010 the estimated worldwide numbers of men and women with AF were 20.9 million and 12.6 million, respectively, with higher incidence and prevalence rates in the developed countries (2). In Denmark, the prevalence of AF is approximately 93,000 and the incidence about 20,000 new cases per year (3). Estimated number AF-patient in local department is 400/ year. AF is a costly public health problem with hospitalizations as the primary expenditure (4). The disease and treatment is complex and requires a high degree of adherence to prevent complications (stroke and major bleedings) and the burden of symptoms often leads to poor health related quality of life (HRQOL). The impairment of HRQOL due to AF can be comparable to that observed in patients with heart failure which is due to both the often disabling symptoms of the disease, and the risk of complications such as stroke (5) (6). The consequences of AF are often impairment of physical functioning and mental health (7). A qualitative study by McCabe et al. found that AF patients often are anxious. They have feelings of nonsupport, inadequate self-management counseling, and distress associated with the unpredictable symptoms (8).
Illness is considered to be a family affair and it is therefore important for patients and their families to have a chance to talk about issues like suffering and coping (9). Families need support and solutions to ensure successful adjustments to adequately cope with a family member with chronic illness (10). Little is known about how families experience to habituate life with AF, their concerns and feelings and their need for support. One study found that the greatest burden to family members of AF patients occur due to disruption in schedule, followed by financial problems, lack of family support and health problems (11). It has also been described how couples where one suffer from AF often experience uncertainty as a common main concern which is rooted in not knowing enough about the disease (12). Studies have shown that health care providers should not only focus on the patient with AF but should take the family into account as well, when managing this condition because the feelings and illness beliefs affect the entire family (13). Future research and intervention should therefore include the whole family.
Hendriks et al. studied the effect of nurse-led care (focused on AF guidelines and patient information) versus usual care for patients with AF. Nurse-led care was superior to usual care in terms of cardiovascular hospitalizations and cardiovascular mortality (14). These findings have generated more attention towards patients with AF and the possibility that they could benefit from specific disease management and rehabilitation similar to programmes used in other chronic cardiovascular conditions such as heart failure and ischemic heart disease (15)(16). However, no clinical guidelines ensure patients and families education to cope with AF. Furthermore, the limited intervention studies are tested in different settings with AF-patients and with different clinical intervention contents. European Society of Cardiology recommend that more research about care for patients with AF are needed and it is likely to require different designs in different healthcare settings (2). More research should focus on testing new intervention models that could benefit patients and their families.  (17). However the efficacy of these models have never been tested in nursing interventions involving patients with AF and the possible potential still needs to be proved (12) (18). Optimization of quality and coherence of the patient experience are recommended for patients with heart diseases, where patients and families are the center point of care (16). Unfortunately, these visions are not always realized in practice for patients with AF (19). Therefore, more research is needed about how healthcare professionals can involve, support and educate AF-patients and their families. In future studies of FFN a new pilot study about how AF-patients experience the patient course should be taking in to account. The themes were "Uncertainty as a companion in the process", "To understand what is wrong with me", and "to put the heart at the right place"(20).
The rising number of patients with AF, the complexity of the disease and treatment, the frequent non-adherence to treatment, the poor QoL, and lack of support for the family demands attention in the management of AF and in how patients and their families cope with the disease. Evidence of the effect of integrating the family in the counselling of patients are in general sparse (21). To facilitate evidence-based knowledge this study is designed to test a health promoting intervention for patients with AF and their families.

Aim and research questions
The aim of the study is to examine how AF-patients and families are influenced by AF and to test if involving family members in a FFN intervention with group education improves outcomes for patients with AF. The aim can be achieved by answering the following research questions.

Study 1: How does family members and AF patients experience family life being affected by AF?
Study 2: How do family members experience life with a family member having AF?
Study 3: Is a short-term educational and family focused support intervention for patients and family members living with AF more effective on quality of life than standard care?

Method
The study will consist of three sub-studies. A qualitative explorative study with family unit interviews, focus group interview with members of the family, and a quantitative fidelity study evaluating the effect of a family focused nursing intervention based on CFAM and CIFM

Materials
Inclusion criteria: Men and women > 18 years with newly diagnosed AF (< 4 weeks since diagnose) documented in the patient file and verified by a EKG. Family members must be > 18 years old and defined by the patient: e.g. spouse, son, daughter, near friend or neighbor.
Exclusion criteria: Patients with chronic heart failure according to international guidelines (2).

Study part 1: Family unit interviews
Qualitative data with patients and family members will be collected from a semi-structured interview-guide founded in a structured literature search. Families will be recruited using a purposeful sampling strategy. This method is used to find participants who collectively provide a rich and varied data material. (e.g. difference in gender, age, income, and symptoms). The family interviews will continue until data saturation has been achieved (22) which is estimated to be approximately 15-20 patients including family members. Families will be interviewed at home or at the hospital according to their preferences. A qualitative methodological approach employing Giorgi's descriptive phenomenological method will be used to collect and analyse data which follows four steps 1: The data is read to give an overall impression. 2: Meaningful units are identified. 3: Meaningful units are transformed into categories. 4: Categories are synthesised into the essence of the phenomenon. The researcher's disciplinary perspective and professional sensitivity will guide the process (23) and the researchers preunderstanding will be revealed by a peer interview prior to the data collection. The study will broaden the perspective of how the family are influenced by AF, their thoughts and feelings can be used as inspiration in the intervention study and benefit in how to support AF patients in clinical health care.

Study Two: Focus group interviews with family members
Data will be collected from 2 -3 focus group interviews each with approximately 5-8 family members. Focus group interviews can be helpful when facilitating the perspectives and opinions of the family members (24). The motive is to attain a condensed and broad description of a phenomenon (25) (26) and to bring positive dynamics into the focus groups, which can help informants to talk about feelings regarding their experiences of being part of a family where a family member has AF. Interview data will be recorded and transcribed ad verbatim and will be analyzed with qualitative content analysis (21). Content analysis is a research method widely used in health care research and it is known for making replicable and valid conclusions from data to their context, with the purpose of providing knowledge, new insights, a representation of facts and a practical guide to action (26).
The gathered knowledge from study 1 and 2 will be used to test the fidelity of a health promoting intervention for AF patients and their families.

Study three: Fidelity study
The fidelity study is designed as a randomized clinical trial. Based on sample-size calculation 100 patients will be allocated in two groups by a computer program. An intervention group (n=50), and a control group (n=50), respectively. The intervention group will receive health promoting group education and sessions based on the theoretical framework of FFN including CFAM and CFIM as a supplement to conventional care and treatment according to international guidelines (2). The interventional focus is on the psychological and educational needs of patients with AF and their families (e. g medication, handling of symptoms, managing stress and anxiety, facilitating the lifestyle changes, exercising, returning to work, and taking part in family and social activities) (27).
The control group will receive conventional care and treatment according to guidelines (2). Conventional care is characterized by ad hoc management as per usual standards of clinical care in Denmark (with access to routine medical care, hospital care, and pharmacotherapy). Patients will be assigned to the fidelity study according to the described in-and exclusion criteria.
The intervention will take place in the Department of Cardiology at Amager Hvidovre Hospital (AAH) and the inclusion period is estimated to one year.

Description of the intervention:
In FFN based on CFAM and CIFM the whole family is considered the unit of assessment and intervention when a member of the family becomes ill (28). In FFN the focus is therefore not only on the patient but on the interaction and the reciprocity between family members, patient and between the nurse. FFN is operationalized within a therapeutic relationship and conversations between a patient / family and a nurse. The idea is to soften illness suffering by creating a context for changing the perspective on illness beliefs and facilitating beliefs that can strengthen the psychological resilience (29). To guide the patient and the families the Family Strength Orientated Therapeutic Conversations (FAM-SOTC) will be used as health promoting conversations and a way to enhance family health (28). The therapeutic conversations build on different theories: System theory, change theory and communication theory. Focusing on illness narrative, therapeutic questions, strengths, identification on psychological endurance and resources and through evidencebased information and recommendation (10).
First part of the intervention is a two hour group session designed by the PhD student and the project nurses based on clinical guidelines of AF-management (2) and theory from multifamily group intervention (30). Nurse specialists will facilitate knowledge to patients and family members about AF and how to support self-management in their daily living. Furthermore during six months´ patients in the intervention group will receive 3-5 FAMT SOCT sessions of 30-60 minutes. First session will start as soon as possible and the nurse, patient and family will plan the numbers and session intervals according to the patient and the family needs of support and guidance. The PhD student and two project nurses from the ward will be trained theoretically and practically in performing health promoting family conversations at Linné University in Sweden.

Study design, study outcomes, and statistical methods
To assess the fidelity of the study, a process evaluation will be carried out (31). This will be done by recording all nursing sessions. It will be used to evaluate if the planned intervention is carried out as intended. Process evaluation is very suitable to evaluate the process and to give an estimate of the fidelity of the intervention. It can also explain reasons for success and failure in outcome results (31).
The influence of the intervention is measured quantitatively using internationally validated questionnaires. Measurements of the effect will be collected 24-48 hours after enrollment and follow-up will be made by telephone interviews after 6 months. RedCap database will be used for collecting data and storing data from questionnaires.
The primary outcome is Quality of Life living with AF. This will be accessed with the Atrial Fibrillation Effect on QualiTY-of-Life (AFEQT) Questionnaire (32). Secondary outcomes of interest are family function which will be measured with the Ice Expressive Family Functioning Questionnaire (ICE-EFFQ) and the Ice Family Perceived Support (ICE-FPSQ) (33). Anxiety scores will be measured with the Hospital Anxiety Depression Scale (HADS) (34), AF symptoms measured with the EHRA scale (European Heart Rhythm Association) (35) and number of hospital admissions registered from The National Patient Registry.
Baseline data will be compared between the intervention group and the standard care group. For demographic data Pearsons X 2test or Fisher´s exact test will be used. Depending on the distribution the independent t-test or Wilcoxon rank-sum test will be used. Normally distributed data will be presented with a mean and a standard deviation (SD), non-parametric data with median and inter quartile range. It is estimated that a sample size of 50 patients in two arms (100 patients total) will make it possible to detect a difference of 11 points on the AFEQT (36) with a power of 80 % and a significance level of 0.05. Calculation are based on a two-sided independent two-sample t-test. An increase between 6 and 19 points has been suggested to correspond to a meaningful improvement in Quality of life measured on AFEQT (36).

Ethical consideration and approvals
The study will be registered to the Danish Data Protection Agency under The Capital Region and the Scientific Ethical Committee. All participants in the studies will receive written and oral information about the study and provide written informed consent regarding participation, which they can retract at any time in accordance with the Helsinki declaration (37). All data will be treated confidentially and anonymized. Qualitative data are stored securely in locked electronic file at AHH and data from quantitative data are securely stored in RedCap database.

Presentations
Three scientific manuscripts will be written with the following preliminary titles for publishing in international journals: • Family function and atrial fibrillation-from a perspective of the patient and family.
• Living with atrial fibrillation-experiences from family members.
• A prospective randomized controlled fidelity study of an educational and family focused intervention for patients with atrial fibrillation Negative, inconclusive and/or positive results will be published and communicated nationally and internationally in peer-reviewed health journals and presented at symposias and interdisciplinary conferences.

Perspectives
It is expected that the study will provide a new understanding and evidence based knowledge on how to incorporate health promoting conversations and education of patients and their families into the AF management and care. In the future, results from the fidelity study can be used to design a randomized controlled trial which could determine the possibilities and limitations of a tailored health promotion intervention for patients with AF, expecting to benefit both patients with AF and their families.

The study plan and financing
The project is expected to be initiated in February 2019 and it will be completed in three years (appendix 1.) In 2019, the first two sub-studies will be performed and education of project nurses will take place. In 2020, the third sub-study with intervention will be performed, and in 2021 all data and results will be analyzed and published. Ongoing financial support is being sought from relevant funding sources. Guarantee for cover of all payroll costs has been given by the Department of Medicine (Medicinsk Enhed) at AAH in case external funding is not obtained.